Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ® UNIPER® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. PORTEX ® UNIPER® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF Back to Search Results
Catalog Number 100/897/090CZ
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/24/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
One portex ® uniper® adjustable flange tracheostomy tube was returned for analysis in used condition.Visual inspection of the tracheostomy tube showed no issues.The inflation test was repeated on the received sample and no leakage was observed after 12 hours.
 
Event or Problem Description
It was reported that "balloon lost tautness slowly after inflation" after intubation.No serious injury was reported in connection with this incident.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX ® UNIPER® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
Common Device Name
TUBE TRACHEOSTOMY AND TUBE CUFF
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7466047
Report Number3012307300-2018-01148
Device Sequence Number1716527
Product Code JOH
UDI-Device Identifier15019315107214
UDI-Public15019315107214
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K083031
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number100/897/090CZ
Device Lot Number3292118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/26/2018
Initial Report FDA Received Date04/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-